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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01571544
Other study ID # R12038
Secondary ID
Status Completed
Phase Phase 4
First received March 29, 2012
Last updated January 3, 2017
Start date November 2012
Est. completion date November 2014

Study information

Verified date January 2017
Source Tampere University Hospital
Contact n/a
Is FDA regulated No
Health authority Finland: Ethics Committee
Study type Interventional

Clinical Trial Summary

Unintentional hypothermia of a patient is a common adverse effect during surgical procedures. The aim of this prospective, randomised, controlled study is to determine whether the use of thermal suit could prevent surgical patient from experiencing thermal loss than conventional measures.

Hypothesis: The investigators assume that a difference of 0.5°C in body temperature between the groups is clinically relevant.


Description:

The aim of this study was to compare a thermal suit (T-Balance) and conventional warming methods to maintain a constant body temperature in patients undergoing robotic laparoscopic radical prostatectomy under general anesthesia.

A sample size calculation was made using a power analysis. Patients were randomly allocated into two groups.

Patients in the intervention group were put on the T-Balance 1 hour before anesthesia induction. Patients in the control group got conventional cotton clothes. Intra-operatively same warming methods were used in both groups. The measuring points of the temperature were esophagus (core temperature), left axilla, dorsal surface of the left middle finger and back of the left foot.

Anesthesia was induced via target-controlled infusion. All temperature data of the patients were collected and recorded electrically and continuously.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date November 2014
Est. primary completion date April 2013
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria:

- radical prostatectomy, American Society of Anaesthesiologists class I-III, age 18-90

Exclusion Criteria:

- mental status with inability to give informed consent, neuromuscular disorders, Raynaud`s disease, unstable angina pectoris

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Device:
Thermal suit
Thermal suit
Other:
Conventional clothing
Conventional clothing

Locations

Country Name City State
Finland Tampere University Hospital Tampere

Sponsors (1)

Lead Sponsor Collaborator
Tampere University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Temperature from one hour before surgery up to the ward after surgery, estimated 10 hours No
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